Table of contents
Nguyen Injury Lawyer is closely monitoring Elmiron vision loss lawsuits across the country. This page offers the latest updates on the Elmiron class action lawsuit and our insights on potential settlement amounts for victims of vision loss and blindness. Settlements have been reached in 2024, and many victims are either receiving checks or will soon. While Nguyen Injury Lawyer, like many firms, is no longer accepting new Elmiron clients, we remain committed to keeping you informed.
Related lawsuits: Ozempic NAION lawsuits
Elmiron’s Side Effects
Elmiron, a prescription medication manufactured by Janssen Pharmaceuticals, is commonly prescribed to treat chronic bladder conditions. It was frequently the first line of defense for patients with interstitial cystitis (IC) and initially appeared to have few side effects, generating significant revenue for Janssen. However, research later revealed that prolonged Elmiron use could lead to severe retinal damage. Subsequent studies have confirmed that long-term, high-dose use of Elmiron can cause permanent vision impairment and blindness.
Following these findings, numerous dangerous drug lawsuits have been filed against Janssen, alleging vision loss and damage caused by Elmiron. Over 1,740 Elmiron lawsuits have been filed in federal court, with additional cases in state courts.
Typical Elmiron Lawsuit Plaintiff
Nguyen Injury Lawyer receives calls daily from individuals harmed by Elmiron. A typical case involves:
- A diagnosis of interstitial cystitis (IC), a chronic condition with no cure.
- A doctor prescribing Elmiron with minimal warnings about side effects or risks.
- Initial success in managing IC symptoms with Elmiron.
- An increasing dosage of Elmiron over time, with no warnings from the prescribing doctor.
- The gradual onset of vision problems, such as difficulty adjusting to light, impaired color perception, reduced night vision, or balance issues.
- A worsening condition.
- A diagnosis of pigmentary maculopathy, toxic maculopathy, or another vision-related injury.
- A delayed realization of the connection between Elmiron and the eye injury, discovered through online research or television commercials.
This is a recurring narrative that our attorneys hear frequently.
Elmiron MDL Class Action Lawsuit Update
Here are the latest developments in the Elmiron class action lawsuit:
May 2025 Update
The number of active Elmiron cases is gradually decreasing, with the MDL dropping to 1,028 active cases from 1,049 last month. Settlements continue to be finalized.
July 2024 Update
Settlements continue to progress. The Elmiron MDL saw a decrease in active lawsuits from 1,750 in June to 1,588 in July 2024, and this number is expected to continue to decline.
March 2024 Update
The Philadelphia Elmiron litigation is nearing completion. The initial trial was scheduled to begin on Monday, but most cases, similar to the federal MDL, have been resolved through private agreements over the past six months. Only a small number of the approximately 150 cases in the Philadelphia group lawsuit remain unresolved and may proceed to trial, but without a bellwether case. In addition to the federal MDL and the Philadelphia group lawsuit, there is a smaller multi-county litigation in New Jersey state court, which is also reportedly approaching its final stages.
Nguyen Injury Lawyer is providing these updates for informational purposes, as we are not currently accepting new Elmiron cases.
February 2024 Update
Judge Brian R. Martinotti has mandated that all plaintiff’s attorneys interested in settlement discussions attend a settlement conference on Friday, February 23, 2024, at 10:00 AM in Newark, New Jersey. Clients must be available by phone during the conference.
January 2024 Update
The number of Elmiron cases remains at 1,916, consistent with the figure from two months prior. While some settlements have been finalized, most are still in progress.
November 2023 Update
The Elmiron MDL decreased by four cases, marking the first monthly reduction in pending cases and indicating that the class action is winding down. The total number of cases is now 1,916.
The Elmiron class action MDL is unlikely to reach 2,000 plaintiffs. There are 1,920 pending cases, but no new cases have been added in over two months. Many plaintiffs with pending cases have already agreed to settlements, and their cases will be dismissed upon finalization. However, it may not be too late to file an Elmiron lawsuit. Nguyen Injury Lawyer is still evaluating these cases.
October 2023 Update
The Elmiron class action MDL is winding down, as evidenced by the single entry on the September MDL docket: an order granting plaintiffs permission to use Esquire Bank for the common benefit fund.
September 2023 Update
The Elmiron class action MDL now has 1,915 pending cases, down from 1,925 three months ago. This number is expected to continue decreasing as more settlements are finalized.
Updates are becoming less frequent as cases settle. Negotiations are ongoing, but settlements are not global; Janssen is settling with individual law firms.
July 2023 Update
July 18, 2023 Update:
Only three new cases were transferred into the Elmiron class action MDL in the past month, the lowest monthly volume since the litigation began, reflecting the rapid wind-down of this class action. Most of these cases have already agreed to settlements but will remain pending for months while the settlements are finalized.
July 7, 2023 Update:
Following the cancellation of the previous two, the next Case Management Conference is scheduled for June 14, 2023. The focus of this litigation has shifted from trial preparation to settlement negotiations.
July 1, 2023 Update:
These cases are settling, and many victims are likely to receive settlement checks this year. If you believe you may have a claim, now is the time to act.
June 2023 Update
June 16, 2023 Update:
As the Elmiron lawsuits progress through the settlement phase, new cases are still being added to the MDL. Over the past month, 32 new Elmiron cases were transferred into the MDL, bringing the total number of plaintiffs to 1,923.
June 2, 2023 Update:
The Elmiron litigation has transitioned into settlement and wind-down mode. The MDL docket had only one entry for May: an order canceling the monthly status conference with Judge Martinotti. This lack of activity reflects Janssen’s ongoing negotiations for block settlement deals with plaintiffs’ firms.
May 2023 Update
May 19, 2023 Update:
The next Case Management Conference is scheduled for June 14, 2023.
May 16, 2023 Update:
Only three new cases were transferred into the Elmiron class action MDL in the past 30 days, the lowest monthly increase since the Elmiron litigation began. This slowdown is not surprising, as Janssen is currently working out large block settlements with plaintiffs’ firms, leaving the MDL in a somewhat inactive phase.
May 1, 2023 Update:
Unlike the lengthy wait times for settlements in cases like Roundup, the Elmiron litigation is different. Most victims can expect to receive their settlement checks within months, not years.
April 2023 Update
April 27, 2023 Update:
With Janssen pursuing its strategy of settling large blocks of Elmiron cases, the plaintiffs’ lawyers are determining the percentage of gross settlement proceeds to be held back to pay attorneys who worked on the plaintiff leadership committee (PLC) in the MDL. The PLC lawyers are requesting an 11% holdback, which would reduce the fees available for non-PLC plaintiffs’ lawyers. One non-PLC firm has filed an opposition, arguing that 11% is unreasonably high compared to holdbacks in other, more complex MDLs.
April 18, 2023 Update:
The Elmiron class action MDL has seen an increase in vision damage lawsuits, with 10 new cases added in the past 30 days, bringing the total number of plaintiffs to 1,889. This number is expected to decrease significantly as Elmiron settlements lead to dismissals.
April 1, 2023 Update:
Another five new Elmiron vision damage lawsuits were added to the class action MDL in the past month, increasing the total number of pending cases to 1,879. The first bellwether test trial is still scheduled to begin in less than two weeks. A settlement is still the most likely outcome.
March 2023 Update
March 18, 2023 Update:
This post explains the current status of an Elmiron settlement in March 2023.
February 2023 Update
February 26, 2023 Update:
In the past month, 31 new Elmiron vision damage lawsuits were filed in the class action MDL (or transferred in from other districts), bringing the total number of pending cases to 1,872. The Elmiron MDL has averaged 22 new cases each month over the past six months. An Elmiron settlement is expected soon, and if you have a claim, now is the time to contact Nguyen Injury Lawyer.
February 3, 2023 Update:
An example of a recently transferred Elmiron lawsuit is Padelford v. Janssen Pharmaceuticals Inc., et al. (2:23-cv-265), filed directly in the Elmiron MDL on January 18, 2023.
The plaintiff, an Arkansas resident, took Elmiron daily for her IC from 2001 to 2008. The complaint alleges that neither she nor her doctor received any warning about the risk of potential eye injury from Elmiron. Padelford’s lawsuit claims that her long-term Elmiron use caused serious eye damage and impaired vision. The lawsuit presents six separate causes of action, with the primary claim being strict liability based on failure to warn.
January 2023 Update
January 30, 2023 Update:
Pretrial motions have been filed and fully briefed in the Elmiron case scheduled for the first bellwether test trial at the end of March: Windham v. Jansen Pharmaceuticals, et al. (20-cv-14670). The defendants filed summary judgment motions and motions to exclude expert testimony, and the plaintiff moved to block some defense experts. The motions were all filed under seal. These are typical motions filed in the months leading up to a bellwether trial.
January 17, 2023 Update:
With the first Elmiron trial just two months away, the slowdown in new Elmiron lawsuits continues. Only three new cases were added to the Elmiron class action MDL this past month, the fewest since the MDL began two years ago. This could indicate that the Elmiron class action is entering a new phase with only a small number of new filings each month.
January 9, 2023 Update:
Elmiron Lawsuit Updates
The number of new Elmiron lawsuits filed slowed down in the latter half of 2022, but people are still filing lawsuits for vision damage allegedly caused by the drug. For example, Keys v. Janssen Pharmaceuticals, Inc., et al. (2:22-cv-07487) is a recent lawsuit involving an Arkansas resident who took Elmiron for interstitial cystitis for many years. She was later diagnosed with pigmentary maculopathy linked to her Elmiron use, resulting in impaired vision. The lawsuit was filed directly into the Elmiron class action in New Jersey.
January 1, 2023, Update
The Elmiron vision damage class action has seen reduced activity in the second half of the year. In the early months of 2022, the MDL was growing by over 200 new Elmiron lawsuits each month, putting it on track to reach 2,000 total cases by mid-summer. However, the pace slowed considerably. Only 55 new Elmiron plaintiffs joined the MDL in the last month, bringing the year-end total to 1,839. The MDL docket has also been quiet, with only one entry in December: a notice that the monthly status conference was canceled.
December 2022 Update
December 6, 2022, Update: Nguyen Injury Lawyer posted an update on the status of the Elmiron lawsuits as of December 2022. Contact Nguyen Injury Lawyer at XXX-XXX-XXXX or visit https://www.nguyeninjurylawyer.com/contact for more information.
November 2022 Update
November 17, 2022, Update: The Elmiron class action lawsuit experienced rapid growth in early 2022. Between January and July 2022, over 1,000 new Elmiron vision loss cases were added to the MDL, representing a growth rate of nearly 300%. Since late July, only 59 new cases have been added, bringing the total to 1,784.
Unless there is a significant increase in new Elmiron case filings during the winter, the MDL is unlikely to exceed 2,000 cases before the first bellwether trial next year. Nguyen Injury Lawyer believes that smaller litigation can lead to more affordable settlement payouts for defendants. If you have an existing Elmiron lawsuit, this development could be beneficial.
November 7, 2022, Update: The first bellwether trial in the Elmiron vision damage MDL, initially scheduled for early 2023, was expected to significantly impact the valuation of these cases and facilitate a global Elmiron settlement. However, the MDL judge postponed the trial date from January to March 27, 2023. The reason for the postponement is unclear.
October 2022 Update
October 28, 2022, Update: The opening bellwether trial in the Elmiron vision damage MDL, previously set for January 2023, has been postponed to March 27, 2023. The outcome of this trial is anticipated to significantly influence the valuation of the cases and progress towards a global settlement. The reason for the postponement is not stated in the court order.
October 22, 2022, Update: The Elmiron MDL now includes 1,784 lawsuits. Only ten new Elmiron cases were added in the past month, marking the third consecutive month of minimal growth. Earlier in the year, the Elmiron MDL was among the most active, with an average of over 100 new filings each month.
October 12, 2022, Update: The first Elmiron lawsuit, Windham v. Jansen (2:20-md-2973), is approaching trial. With the trial date a few months away, MDL Judge Martinotti issued a Case Management Order finalizing key pre-trial dates and deadlines. Briefings on expert witness challenges under Daubert concluded by November 10, 2022. Both sides were required to submit witness and exhibit lists for trial by December 2, 2022, with objections due by January 6, 2023. The pre-trial motions hearing will be held on January 16, 2022, and the trial will begin on January 30, 2023.
September 2022 Update
The Elmiron class action judge issued a housekeeping order following the most recent monthly status conference. The order contained routine administrative matters.
September 15, 2022, Update: The Elmiron class action MDL appeared to be rapidly expanding earlier in the year, with 200 new vision loss cases added monthly. However, the pace of new Elmiron vision loss lawsuits has slowed. The latest JPML report indicated a total of 1,774 cases pending in the Elmiron MDL, an increase of only 34 cases in the past month (August-September). The first bellwether trial is scheduled for January, with the second and third set for March and May. A settlement could potentially be reached before the January trial. A significant verdict could raise awareness and encourage more people to connect their vision impairment to Elmiron use.
September 2, 2022, Update: Following the recent monthly status conference, the Elmiron class action judge issued a housekeeping order with routine administrative matters.
The Windham case is set for the first bellwether trial, and Manning will be the third test trial next year. The defense will select a new bellwether case by the end of September 2022, which will be the second case to proceed to trial.
The rate of new Elmiron lawsuits has decreased in the past month, with only 15 new victims filing Elmiron eye damage lawsuits. There are over 1,700 eye injury claims in the federal class action and approximately 170 lawsuits pending in New Jersey state court.
August 2022 Update
August 18, 2022: The interstitial cystitis (IC) drug market is projected to grow by over 50% in the next six years and 6.6% this year.
August 17, 2022: In the past month, only 15 new cases were added to the Elmiron MDL. As of August 15, 1,740 cases were pending in the MDL, with an additional 169 cases pending in New Jersey state courts.
August 16, 2022: Following the recent monthly status conference, the Elmiron MDL Judge issued a housekeeping order confirming that the Windham case will be the first bellwether trial and Manning will be the third test trial next year. The defense will select a new bellwether case by the end of the month, which will be the second case to proceed to trial.
August 8, 2022: July was a quiet month for the Elmiron class action lawsuit. No new cases were added after July 7, 2022, following a record-high number of cases being transferred into the MDL. Judge Martinotti held a status conference on July 13, 2022, resulting in an order regarding appointments to the Plaintiffs’ Steering Committee. Since then, there have been no additional docket entries. Nguyen Injury Lawyer believes the small size of the Elmiron lawsuit might be a good thing for Elmiron settlement amounts for victims.
July 2022 Update
The Elmiron vision damage lawsuits have been a prominent mass tort this summer. Between June 15 and July 15, 365 new plaintiffs with Elmiron vision damage claims were added to the MDL, bringing the total number of pending cases to 1,725.
The addition of nearly 400 new cases represents the most significant monthly increase since the start of the Elmiron MDL and the largest percentage increase of any mass tort during that period. The opening round of Elmiron bellwether trials is approaching.
June 2022 Update
The Elmiron eye damage class action includes 1,360 plaintiffs. Nguyen Injury Lawyer initially anticipated this litigation to be larger, but many people with eye damage have not connected their injuries to Elmiron.
However, the past month saw 326 new Elmiron eye damage lawsuits added to the MDL class action. This is the most significant monthly increase in new Elmiron lawsuits and may indicate increased awareness. It was also one of the largest increases in new cases of any mass tort MDL in the country.
May 2022 Update
Three Elmiron lawsuits have been selected for the first round of bellwether trials in the Elmiron MDL:
- Windham (20-cv-14670)
- Manning (21-cv-11942)
- Broussard (21-cv-2028)
Details on These Three Elmiron Bellwether Lawsuits
Broussard and Windham were defense picks, while the plaintiffs’ committee selected Manning. Broussard’s complaint lacks specific details about the duration of Elmiron use, stating only “loss of vision.” Elmiron defense lawyers chose this case to push to trial.
Maria Windham, a 67-year-old from Louisiana, claims to have developed macular eye damage after taking Elmiron for two years.
Julia Manning is a resident of Georgia. Her case appears to be the strongest of the three, as she took Elmiron for six years and suffered damage in both eyes.
Elmiron Scheduling Moving Forward
The judge in the Elmiron MDL followed up his selection of the three bellwether trial cases by issuing a new Case Management Order revising the pretrial discovery and trial schedule for the 3 cases.
For all 3 cases, discovery must be concluded by September 9, 2022 and the plaintiffs will be allowed five depositions per case. Dispositive motions are due by September 20.
The first bellwether trial will commence in January 2023. The second bellwether trial will be in March and the third and final trial will be in May 2023.
Getting Close to 1000 Elmiron Lawsuits
There are now 900 Elmiron lawsuits in the MDL class action.
April 2022 Update
Following the March Monthly Status Conference, the Elmiron MDL Judge issued Case Management Order No. 27, providing an updated status of the Elmiron litigation as of March 9, 2022. The court is closely monitoring the number of Elmiron lawsuits filed, which includes 803 Elmiron product liability lawsuits: 712 in the federal Elmiron class action lawsuit and 91 suits pending in New Jersey state court. The “Elmiron Science Day” was rescheduled for the third time, with a new date to be determined.
March 2022 Update
The judge in the Elmiron MDL issued a series of Case Management Orders last week, setting the stage for the next phase of litigation in preparation for the first bellwether trials in January. Judge Martinotti ordered the parties to submit a joint proposal for the final selection of the first bellwether cases. Fact discovery in the pool of bellwether candidate cases will conclude at the end of the month, and the initial bellwether trial pool cases will be picked by April 8. The “science day” will take place, and a mandatory Case & Claim Data Form (“CCDF”) was approved and must be submitted by all plaintiffs within 30 days.
February 2022 Update
There are currently 736 Elmiron lawsuits in the MDL. The Supreme Court of New Jersey ordered that all Elmiron vision loss lawsuits pending against Janssen Pharmaceuticals in the New Jersey state court system will be consolidated for pretrial administration, similar to an MDL. The New Jersey Elmiron lawsuits will be consolidated in Bergen County, New Jersey, where Janssen is located.
January 2022 Update
An Elmiron MDL (In Re: Elmiron (Pentosan Polysulfate Sodium) Prod. Liab. Litigation, MDL 2973) was established in the U.S. District Court for New Jersey under Judge Brian Martinotti.
As of December 15, 2021, almost 800 Elmiron lawsuits are pending in the MDL. If you believe you have suffered vision damage due to Elmiron, contact Nguyen Injury Lawyer at XXX-XXX-XXXX or visit https://www.nguyeninjurylawyer.com.
Judge Martinotti, who has extensive experience with MDL class action cases, has been actively managing the pre-trial discovery phase for these eye injury and blindness claims. While the litigation process may experience a slight slowdown during the Christmas season, legal teams are expected to vigorously pursue Elmiron lawsuits starting in January.
Early in the new year, Judge Martinotti intends to conduct a “science day,” providing an opportunity for both sides’ attorneys to present the court with a comprehensive overview of their respective medical and scientific evidence. The initial bellwether trials in the Elmiron litigation are scheduled to commence in March 2023 (previously January 2023).
Considering the compelling scientific evidence linking Elmiron to pigmentary maculopathy, it is conceivable that a global settlement of these cases could be reached before any bellwether trials take place.
Is There an Elmiron Recall?
Currently, there has been no Elmiron recall. Despite emerging evidence suggesting that prolonged Elmiron use may lead to macular eye damage in some individuals, the drug remains available by prescription for treating IC. However, following the release of this new research, the FDA mandated that Janssen update Elmiron’s warning label.
Elmiron now carries a “black box” warning, which explicitly informs patients and healthcare providers about the potential risk of macular eye damage associated with long-term use. This type of warning is the most serious label that can be applied to a pharmaceutical product. The inclusion of this enhanced warning on Elmiron underscores the strength of the causation evidence presented in the Elmiron cases.
You might expect Nguyen Injury Lawyer to advocate for an Elmiron recall. However, we believe Janssen acted responsibly in 2020 by updating the warning label. Patients have the right to make informed choices and assess potential risks. Elmiron lawsuits primarily address the harm caused before the warning change in 2020.
How an Elmiron Settlement Would Work
The scientific evidence establishing a link between Elmiron and a specific type of vision damage is substantial. In the past, mass tort cases involving hazardous drugs have resulted in significant settlements, even with less compelling medical evidence. Our attorneys at Nguyen Injury Lawyer are optimistic about these lawsuits, and while litigation outcomes are never guaranteed, we anticipate that substantial settlement offers may be extended to Elmiron victims. Contact us at XXX-XXX-XXXX to discuss your options.
The Elmiron class action MDL is highly likely to be resolved through a settlement. The key questions are the settlement amount and the structure of the Elmiron settlement agreement.
Global settlement amounts in mass tort cases typically involve a structured payout system where individual lawsuits are categorized into tiers based on a points system. Envisioning an Elmiron settlement in terms of tiers is a helpful way to understand potential compensation payouts.
Elmiron lawsuits assigned to the highest tier receive the largest settlement payouts, while those in the lower tiers receive smaller payouts. Tier placement is determined by the severity of the plaintiff’s injuries.
For instance, a plaintiff experiencing 100% vision loss would be placed in the highest tier, whereas a plaintiff with only partial vision impairment would be in the lowest tier.
How Do You Know if Elmiron Damaged Your Vision?
Research has definitively linked Elmiron use to a particular type of eye damage that is exclusively associated with the active ingredient in Elmiron (pentosan polysulfate sodium). This unique eye condition is known as pigmentary maculopathy.
Individuals who have taken Elmiron for a year or longer should undergo eye examinations to check for retinal damage. The eye damage related to Elmiron is frequently misdiagnosed as age-related macular degeneration, so it is crucial to inform your eye doctor about your history of Elmiron use.
What Are the Symptoms of an Elmiron-Induced Eye Injury?
The symptoms of an Elmiron-induced eye injury may include:
- Blurred vision and distorted vision
- Muted colors
- Changes in eye color
- Increased light sensitivity
- Dark spots, blind spots, and floaters
What Elmiron Settlement Amounts Should We Expect in an Elmiron Lawsuit?
Drawing upon settlements in previous mass tort drug cases and the strength of the evidence in this litigation, our lawyers at Nguyen Injury Lawyer estimate the following potential Elmiron settlement amounts:
| Vision Impairment Level | Settlement Range |
|---|---|
| 80% – 100% | $750,000 – $1,000,000 |
| 40% – 80% | $350,000 – $700,000 |
| 20% – 40% | $75,000 – $200,000 |
| Under 20% | $25,000 – $50,000 |
Please understand that these figures are speculative. However, we share these estimates because victims understandably want to know what lawyers familiar with Elmiron cases believe their settlement value to be. While these estimates could be significantly off, based on our current understanding, we anticipate that the average Elmiron settlement will range from $350,000 to $400,000, with some settlements exceeding $1 million.
How Long Will an Elmiron Settlement Take?
A final settlement in the Elmiron class action MDL is likely to be reached shortly before or after the first trial in March 2023.
Global settlements in large defective drug cases typically require time. If an attorney promises a quick Elmiron settlement, proceed with caution. However, the Elmiron lawsuits are well-positioned for settlement in 2023, and pre-trial discovery is largely complete. This creates a unique opportunity where filing an Elmiron claim now could potentially lead to a relatively swift settlement.
New Jersey Class Action Elmiron Lawsuits
In addition to the 1,800 Elmiron lawsuits pending in federal court as part of the Elmiron MDL class action, there are also an increasing number of Elmiron cases in state court in New Jersey, where Janssen Pharmaceuticals is based. The New Jersey Supreme Court approved a motion to consolidate these Elmiron cases into an MCL (New Jersey’s equivalent of an MDL). As of January 2023, there are approximately 175 of these claims pending.
Now, all Elmiron lawsuits in state courts throughout New Jersey will be consolidated for pre-trial proceedings before a single judge.
We also acknowledge the presence of Elmiron claims in Canada, as we frequently receive inquiries from Canadian residents about handling Elmiron lawsuits there. Contact Nguyen Injury Lawyer at XXX-XXX-XXXX for more information.
Example Elmiron Pigmentary Maculopathy Lawsuit
Deborah Quick, an Oregon resident, recently joined the Elmiron eye damage litigation as a plaintiff. Quick filed her Elmiron lawsuit against Janssen Pharmaceuticals. Initially filed in U.S. District Court in Oregon, her case was subsequently transferred to the Elmiron MDL.
Quick was initially prescribed Elmiron in 2002 to treat her interstitial cystitis. She took Elmiron daily, as prescribed by her doctors, from 2002 until March 2020 without any interruptions. This Elmiron eye damage lawsuit alleges that after taking Elmiron for an extended period, Quick began experiencing vision problems that gradually worsened.
Quick’s Complaint asserts that it was not until 2019 that her doctor informed her that her vision problems might be linked to her prolonged Elmiron use.
Quick was eventually diagnosed with pigmentary maculopathy, a unique type of macular eye damage known to be caused exclusively by long-term Elmiron use. Quick’s Elmiron pigmentary maculopathy lawsuit primarily alleges failure to warn. In other words, Janssen was aware of the dangers of Elmiron but deliberately concealed them from doctors and patients. The Elmiron lawsuits include various counts, but the central issue is that Janssen knew of the risk and did not allow people to make informed choices.
Research Linking Elmiron to Eye Damage
Elmiron was initially believed to be entirely safe until a chance discovery by a team of eye doctors at Emory Eye Center in Atlanta established the link between prolonged Elmiron use and a novel type of macular eye damage.
Unusual Retinal Pigmentary Changes
In April 2018, a team at Emory Eye Center submitted a letter to the editor of the Journal of Urology reporting findings of unusual retinal pigmentary changes or maculopathy (i.e., any condition affecting the macula at the center of the retina) in 6 female patients on long-term Elmiron treatment (median use of 15.5 years) that did not resemble any other type of retinal disease.
That case series was published online at the end of April 2018. None of the patients had a family history of retinal disease or any pathogenic process predisposing them to such a disease. Of the six , five had received 400mg daily of Elmiron, and one received 300 mg daily. The youngest patient was 23 years old when diagnosed with interstitial cystitis, began showing visual symptoms at 30, and by 37 had the most severe eye damage in the study.
Pigmentary Maculopathy Research at Emory
The Emory researchers also presented at the Association for Research in Vision and Ophthalmology Annual Meeting at the end of Spring 2019. They reported results from a retrospective cross-sectional study that included all Emory Eye Center patients diagnosed with interstitial cystitis within four years.
The authors found 14 cases of Elmiron-related maculopathy in 80 patients exposed to Elmiron and no cases in 139 unexposed patients. The authors concluded a strong association between Elmiron exposure and this specific type of vision-threatening maculopathy.
The Emory research group then teamed with researchers at other institutions to conduct a multi-institutional case series published in September 2019 that analyzed 35 patients with Elmiron-associated maculopathy.
The median duration of use was 14.5 years at a median dose of 300 mg daily. The most common referral diagnosis was macular or pattern dystrophy and/or age-related macular degeneration, and the most common symptoms included blurred vision and prolonged dark adaptation. This study focused on diagnostic methods (i.e., multimodal imaging) and the presentation of this specific form of maculopathy, which proved distinctive from other retinal diseases and conditions.
Kaiser Research
In October 2019, a research team at Kaiser Permanente in California found that out of 140 patients currently using Elmiron for an average of 15 years (and a minimum of five years), 24% had eye damage that increased with the total amount of Elmiron taken.
That team presented their research at the 2019 Annual Meeting of the American Academy of Ophthalmology in San Francisco. The researchers then performed exam screening on 117 patients exposed to Elmiron, of which 23% had definite indications of the unique Elmiron eye damage.
In November 2019, the Emory Eye Center team released results from a U.S. retrospective cohort study using a medical claims database comparing Elmiron users to matched controls at 5 and 7 years of use. At the 7-year follow-up, Elmiron users had a significantly increased risk of developing atypical maculopathy and age-related macular degeneration.
Therefore, this study concluded that ELMIRON “exposure was associated with a new diagnosis of macular disease at the 7-year follow-up in a large national cohort.”
Powerful Elmiron Case Study
Also, in November 2019, a researcher at Harvard published a case study of Elmiron-associated maculopathy that progressed over six years after discontinuing the medication.
The female patient used 200mg per day for 18 years. She presented with a year of visual symptoms at 62 and stopped using ELMIRON shortly after that. She continued to be seen for increasing visual damage throughout the next six (6) years. She was determined to have retinal atrophy and damage that could not be associated with any genetic or other potential cause.
Continued Maculopathy After Elmiron Cessation
Following the release of the Emory case study in 2018, the patient’s healthcare providers concluded that her condition was consistent with Elmiron-associated maculopathy. The study’s authors emphasized that this case “adds a new layer of concern by demonstrating progressive maculopathy continuing for up to 6 years after the cessation of [ELMIRON],” advocating for screening protocols that “balances the demands of patients and physicians with the importance of prompt identification of early toxicity.”
PPS-Associated Maculopathy
In July 2020, researchers from multiple institutions jointly published a retrospective case series to assess the progression of retinal pigmentary changes/maculopathy linked to Elmiron use, also known as “PPS-associated maculopathy.”
The study found that none of the 11 patients with confirmed PPS-associated maculopathy showed noticeable improvement after discontinuing Elmiron. Furthermore, nine of these patients reported a worsening of their visual symptoms.
Medical imaging confirmed that the affected areas of the retina expanded over time. In some cases, atrophy encroached upon the foveal center. This suggests that eye damage can continue to progress even after patients stop taking Elmiron.
Why is Fundus Autofluorescence (FAF) Testing Important for an Elmiron Lawsuit?
Fundus autofluorescence (FAF) is a diagnostic technique that allows doctors to evaluate the health of the retina, the back of the eye. This technology uses a specialized camera to capture images of the retina, revealing its natural fluorescence in response to light.
In Elmiron lawsuits, attorneys use FAF testing as a confirmatory test to link vision loss to Elmiron use.
Example Elmiron Lawsuit
Consider a typical Elmiron lawsuit: Joanne Williams, an elderly woman from Plymouth County, Massachusetts, was prescribed Elmiron to manage pain associated with interstitial cystitis (a bladder condition causing prolonged urine retention). After five years of Elmiron use, Ms. Williams experienced vision loss and filed a lawsuit against Janssen Pharmaceuticals.
At 79 years old, Ms. Williams now suffers from retinal pigmentary degeneration, a preventable cause of vision loss. This injury has significantly impacted her quality of life. Her lawsuit alleges that Janssen Pharmaceuticals knowingly marketed Elmiron to her and her healthcare providers without adequately disclosing the associated risks. Despite this knowledge, the company allegedly failed to modify its product, packaging, guidelines, instructions, or warnings.
This Elmiron lawsuit, like all other Elmiron eye damage lawsuits, centers on Janssen Pharmaceuticals’ alleged failure to warn doctors and patients about the potential for life-altering eye damage and blindness caused by this IC medication.
Reportedly, Ms. Williams’ attorney contacted Janssen Pharmaceuticals to explore a potential settlement before filing a lawsuit. However, Janssen allegedly did not respond.
Contact Nguyen Injury Lawyer About an Elmiron Lawsuit
Nguyen Injury Lawyer is currently accepting new Elmiron cases from individuals diagnosed with eye damage related to Elmiron use. Contact our attorneys today to discuss your case. Call XXX-XXX-XXXX or visit our contact page at https://www.nguyeninjurylawyer.com/contact for a free consultation.